Clearance and Pharmacokinetics of Antibiotics in Renal Replacement Therapy

NCT03714789 | Completed DMC

• 1 other identifier: PKDialysis-201710
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study that evaluates the dialysis clearance and pharmacokinetics of antibiotics with different protein-bound levels in patients receiving renal replacement therapy. Meropenem, vancomycin and ceftriaxone are selected to represent three typical protein-bound levels, and the primary dialysis methods being studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). During and after the dialysis, the drug levels in both plasma and spent dialysate are monitored, but no changes are made to therapy. The study will provide detailed information on the characteristics of the removal kinetics of the three antibiotics during dialysis, and evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets while minimizing the risk of toxicity.

Conditions

Kidney Failure

Keywords

Kidney Failure; Pharmacokinetics; Antibiotics

Outcome Measures

Primary Outcomes (2)

• Dialytic clearance (K_total)

  The total drug amount removed by dialysis

  During the session of dialysis, up to 4 hours

• Area under the concentration-time curve (AUC)

  AUC based on plasma concentration during dialysis

  During the session of dialysis, up to 4 hours

Secondary Outcomes (1)

• Rebound of plasma concentration (Rebound_1h%)

  At the end of dialysis and an hour after dialysis

Study Arms (3)

Meropenem

Patients requiring dialysis and receiving meropenem for infection or suspended infection.

Other: Blood and spent dialysate collection

Vancomycin

Patients requiring dialysis and receiving vancomycin for infection or suspended infection.

Other: Blood and spent dialysate collection

Ceftriaxone

Patients requiring dialysis and receiving ceftriaxone for infection or suspended infection.

Other: Blood and spent dialysate collection

Interventions

Blood and spent dialysate collection OTHER

A certain amount of blood and spent dialysate are collected during and after dialysis for quantification of drug concentration.

Ceftriaxone; Meropenem; Vancomycin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged from 18 to 85 years, requiring dialysis including intermittent hemodialysis(IHD) or hemodiafiltration(HDF), and receiving meropenem, vancomycin or ceftriaxone based on clinical grounds from a university-affiliated hospital in Shanghai, China.

You may qualify if:

• With Age from 18 to 85 years old.
• With weight from 50 to 75 kilograms.
• Requiring dialysis including intermittent hemodialysis(IHD) or hemodiafiltration(HDF).
• Receiving meropenem, vancomycin or ceftriaxone based on clinical grounds.

You may not qualify if:

• Patient is during pregnant or lactation period.
• Patient is allergic to meropenem, vancomycin or ceftriaxone.
• Severe hypoproteinemia (serum total protein\<=45g/L) or severe hypoalbuminemia（serum albumin\<20g/L).
• Severe liver dysfunction（ALT\>200U/L or AST\>200U/L).
• The patient himself or his immediate family refuses to sign the informed consent.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead
• Institute of Antibiotics, Huashan Hospital, Fudan University: collaborator

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Feng Ding, PhD

  Division of Nephrology,Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kidney internal medicine professor

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 22, 2018
• Study Start: November 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: October 1, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

CN (1)